1. Field of the Invention
This invention pertains to formulations and methods for promoting oral hygiene and in particular to formulations and methods for reducing tooth decay by removing dental plaque.
2. Description of the Prior Art
The etiology of dental conditions involves complex interactions of various natural oral substances and chemical reactions between the same and dentifrices. Enough conditions exist to warrant not only a health professional, namely a dentist devoted solely to a person's teeth and gums, but also specialization within that profession. For example, periodontics, endodontics, and orthodontics are some of such areas of specialization. Notwithstanding the relatively large number of professionals devoted to the care and treatment of teeth and gums, it may safely be said that tooth decay caused by bad oral hygiene is one of the more prevalent health problems in the United States today.
Generalized factors that predispose individuals to poor oral health include endogenous (microbiological) hose (habit and custom) and exogenous (diet) aspects.
In terms of microbial concentration, the mouth is perhaps the most "dirty" organ of the body; that is, the potential for infection is greater there than elsewhere. Conditions which are present in the mouth, including an overabundance of nutrients, moisture, a warm ambient temperature, and oxygen are ideal for supporting microbial growth. Microorganisms establish colonies preferentially at various anatomical sites within a person's mouth. Moreover, no two areas of the mouth possess an identical ratio of bacterial flora (microscopic forms of life). Other variables which significantly affect floral patterns include oral pH, chewing habits, hygiene habits, time of day and age of the patient. Hence, in the prior art, no generalized treatment of the mouth exists to effectively prevent caries or related gum disease.
Brushing of the teeth, preferably after eating, is widely recognized as the fundamental method of promoting oral hygiene. Almost everyone prefers to use a commercial dentifrice to brush their teeth. These products come in toothpaste, tooth powder, and the newer dental gel forms. Their composition is fairly standard: a binder to stabilize the suspension emulsions liquid and solid phases, an abrasive to remove debris, a sudser to foam and froth the teeth clean, a humectant to retain moisture, and a flavoring agent. Other active ingredients with claimed therapeutic and/or preventative proprieties such a fluoride, may also be included within the formulations of the prior art. Powder dentifrices normally contain only abrasive and flavoring ingredients.
Studies have shown that dentifrices vary greatly in abrasiveness. In general, while no abrasive is harsh enough to remove enamel, some dentifrices may harm cementum and dentin. These products should be avoided by individuals with periodontal disease and hypersensitive teeth. Identifying the different kinds of offending dentifrices is difficult because the interaction of inert ingredients in each formula (which changes over time) may enhance or retard the effect of the abrasive within the mixture. In general, powders are more abrasive than pastes, and products that claim to be tooth whiteners often are harsher than others. Specific abrasive ingredients which may harm dentin include calcium carbonate, anhydrous dibasic calcium phosphate and silica.
Many therapeutic claims are made about the various dentifrices. However, presently only fluoride containing dentifrices appear to be helpful in preventing dental cavities. Fluoride in each of its various dosage forms partially decreases the incidence of cavities by converting hydroxyapatite in the enamel to a harder and less acid soluble fluoroapatite. Certain desensitizing toothpastes also are promoted as being therapeutically beneficial in treating teeth which are hypersensitive when they are exposed to variations in physical stimuli such as temperature and pressure. Such hypersensitiveness may be caused due to an enamel defect or early pulpitis.
There is a continuing effort in the prior art to obtain additional dental benefits from dentifrices through the inclusion of agents designed to have some specific biological or therapeutic action. Among such dentifrices are those which are claimed to "remineralize" the tooth substance, those which include urea and dibasic ammonium phosphate in their formulas, penicillin, foaming agents, and others which have been promoted as antienzyme, antibacterial and antihalitosis agents. For the most part, when such dentifrices are employed as adjuncts to supervised toothbrushing in controlled clinical investigations, their superiority over conventional dentifrices has not been clearly established.
The term halitosis has become a household word due to intensive commercial advertising. Recent television advertising has implicated bad breath as a causative factor in social insecurity. While no one doubts that bad breath can be offensive, there is some doubt as to whether mouthwash is the solution to the problem as it is advertised. While the lungs contribute a small share to the problem of bad breath, most bad breath problems arise in the mouth. Mouth odor is usually at a peak in the morning due to the combination of bacteria, decaying foodstuffs, and mouth protein, which have stagnated overnight. The involvement of bacteria is the scheme of things has led many manufacturers to include antibacterial agents, for example, quaternary ammonium compounds, tyrothricin, etc., in their products. Claims that an antibacterial can effectively kill the bacteria causing bad breath during the short duration of time of the average gargle are questionable. Secondly, the lining of the mouth is protein and the quaternary ammonium compounds used in many mouthwashes are absorbed and partially deactivated by the protein. Even if these compounds are leached out of the mouthwash by the saliva, there is no evidence to indicate that they are active over the period of a day. They also are indefinitely diluted. It would appear, therefore, that mouthwashes are primarily useful in partially rinsing away collected malodorous materials in the mouth; but, such rinsing may also be effectively accomplished by gargling with water. Some pleasant scent will also remain behind for a little while after gargling with the mouthwash. In general, however, mouthwashes are not significantly effective in eliminating halitosis, but they may mask halitosis for a limited time and cause the user to develop a false sense of security.
Dental plaque comprises a thin, sticky, transparent film that forms continuously on the surfaces of the teeth. Certain bacteria, especially those on the inner surface of the plaque, produce acids that can attack the tooth enamel. Plaque can also build up over time and harden into a complex material called dental calculus or tartar. The mixture of deposits within dental calculus can lead to gum disease and tooth loss as well as tooth cavities. Calculus generally manifests itself by the formation of hard calcified deposits which form at or beneath the edge of the gum. While tooth decay encouraged by plaque would almost be totally prevented by the elimination of plaque, no satisfactory method in the prior art has been found to avert the formulation of bacterial plaque on teeth or to effectively remove the same to prevent buildup. Neither the various dentifrices nor the mouthwashes of the prior art prevent the formation of or permit the removal of dental plaque.
Regular visits to the dentist during which the teeth are thoroughly cleaned are, of course, effective in removing the plaque then built up on the teeth. However, the period of time between such visits allows the plaque to build up and to cause the aforementioned damage.
Accordingly, a major object of the present invention is to provide a formulation which when used on a daily basis, prevents the buildup of dental calculus.
Another object of the present invention is to provide dentifrice composition containing a combination of several active substances which provide special, effective dental care, solving jointly most of the problems of the mouth such as hypersensitivity, halitosis, and plaque.
Another object of the present invention is to provide a dentifrice composition which is foamless and may therefore be used by persons without the need to rinse their mouths after each use.
A related object of the present invention is to develop a dentifrice and method which is effective and yet not taste repugnant to the user.
There are also other objects of the present invention which although may not be specifically stated, may be deduced from the following description and claims and which other objects are intended to be included within the scope of the present invention.